Safety of and Immune Response to Dolutegravir in HIV-1 Infected Infants, Children, and Adolescents

Summary

Participation Requirements

Description

DTG is an HIV medicine in the integrase inhibitor drug class. The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of DTG in HIV-1 infected infants, children, and adolescents. Participation in this study will last approximately 48 weeks, followe...

DTG is an HIV medicine in the integrase inhibitor drug class. The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of DTG in HIV-1 infected infants, children, and adolescents. Participation in this study will last approximately 48 weeks, followed by long-term safety follow-up that will last for about 3 years. Participants may be receiving other antiretroviral (ARV) medications while in this study; these medications will be prescribed by participants' doctors and will not be provided by the study. This study has two stages. Stage I will evaluate the short-term tolerability and safety of DTG, allowing the selection of a dose for further study in Stage II. Stage II will then provide long-term safety, tolerability, and efficacy data for DTG. Participants will be assigned to one of eight cohorts depending on age (4 weeks to younger than 18 years of age). Participants in cohorts I and IIA will receive DTG film-coated tablets; participants in cohort IIB will receive DTG granules for oral suspension or DTG dispersible tablets; participants in cohorts III and IV will receive DTG granules for oral suspension; and participants in cohorts III-DT, IV-DT, and V-DT will receive DTG dispersible tablets. Participants will receive DTG orally once or twice daily, depending on which other ARV medications they are receiving. (All eight cohorts will be included in Stage I of the study; however, Stage II of the study will not include cohort IIB). Stage I participants will undergo a physical examination and have blood drawn at each of 10 study visits, occurring on Day 0; Day 5 (+5 days); and Weeks 4, 8, 12, 16, 24, 32, 40, and 48. Stage I participants will also have their blood drawn 8 times over 24 hours during the Day 5 (+5 days) study visit to measure the amount of drug in the blood stream. Stage II participants will undergo a physical examination and have blood drawn at each study visit (Day 0; Day 10; and Weeks 4, 8, 12, 16, 24, 32, 40, and 48). Blood, plasma, and urine will also be stored and tested to measure immune response. Females of childbearing potential will undergo pregnancy testing at every study visit. Questionnaires and assessments will be performed at select study visits. After 48 weeks, all participants will enter long-term safety follow-up and will continue to receive DTG. During this time, participants will undergo a physical examination, blood collection, and questionnaires at most study visits (every 12 weeks for about 3 years). Note: In January 2018, all participants on DTG granules for oral suspension were recommended to transition to DTG dispersible tablets. Cohorts III and IV are closed to further enrollments.

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